Balloon catheter with enhanced locatability

ABSTRACT

A balloon catheter for insertion in a vessel includes a catheter shaft and an inflatable balloon attached to the catheter shaft. Markings along a longitudinal axis of the catheter are provided in an interior of the balloon, such as for measuring a distance within the vessel. A first distance separating a first marking from a second adjacent marking may be different from a second distance separating the second marking from the third adjacent marking. The markings may also be used for ensuring the proper position of the balloon and, in particular, the working surface thereof, relative to the treatment area.

This application is a continuation of U.S. application Ser. No.16/387,122 filed on Apr. 17, 2019, which is a continuation of U.S.application Ser. No. 15/441,895 filed on Feb. 24, 2017, which is adivisional of U.S. application Ser. No. 14/403,886 filed on Nov. 25,2014, which is a National Stage of PCT/US2013/051863 filed on Jul. 24,2013, all of which are incorporated by reference.

TECHNICAL FIELD

This disclosure relates generally to balloon catheters for performingmedical procedures, such as angioplasty and, more particularly, to acatheter having a predetermined portion, such as a working surface, thatmay be precisely located or identified during use.

BACKGROUND OF THE INVENTION

Catheters including balloons are routinely used to resolve or addressflow restrictions or perhaps even complete blockages in tubular areas ofthe body, such as arteries or veins. In many clinical situations, therestrictions are caused by hard solids, such as calcified plaque, andmay sometimes involve the use of high pressures to compact suchblockages. Commercially available balloons employ complex technology toachieve high pressure requirements without sacrificing the profile ofthe balloon. Besides high pressure requirements, the balloons shouldalso be resistant to puncture, easy to track and push, and present a lowprofile, especially when used for angioplasty.

In clinical practice, an angioplasty balloon 12 may be expanded from adeflated, folded state (FIG. 1) to an inflated, expanded state (FIG. 2)within a vessel at a treatment area T, such as a portion of thecircumferential inner wall of a blood vessel V. The inflation may becompleted using an X-ray contrast agent or media CM filling the balloon12 to a height DX to provide better visibility under X-ray energy XR orother form of radiography during the interventional procedure, asillustrated in FIGS. 3 and 4. Typically, a 70/30 percent mixture ofcontrast agent and saline is used to inflate the balloon during anangioplasty procedure.

In general, a desirable goal is to reduce inflation and deflation timesrequired for balloons without sacrificing the profile of the balloons,especially for large volume balloons (which can require up to twominutes of inflation/deflation times with the contrast agent). Becauseof its relatively high viscosity, it would also be desirable toeliminate, or at least reduce the amount of, the contrast agent used ininflation/deflation of the balloons. The use of contrast agent prolongsthe inflation/deflation times and also poses the risk of iodine exposureto patients sensitive to iodine. In this regard, a non-radiopaquesubstance could be used in lieu of the contrast agent, such as forexample saline or carbon dioxide, but such substances are invisibleduring X-ray imaging, and thus do not help with locating the balloon 12in the desired manner.

Furthermore, the clinician performing the angioplasty procedure shouldbe able to locate the position of the uninflated balloon with accuracy,so that the balloon will be properly positioned once inflated. This isconventionally accomplished by attaching marker bands on the cathetershaft corresponding to the ends of the balloon working surface. This“working surface” is the surface along the portion of the balloon thatis used to achieve the desired treatment effect, such as contacting thecalcified plaque (which surface in the case of a balloon having conicalor tapering sections at the proximal and distal ends is typicallyco-extensive with a generally cylindrical barrel section).

Misalignment of the marker bands during placement along the shaftsometimes results in their failure to correspond precisely to the extentof the working surface, as is shown in FIG. 5 (note misalignment amountX between each interior marker band serving as marking M carried byshaft S and working surface W of balloon 12, which also typicallyincludes a radiopaque tip P at the distal end). Even upon exercisinggreat care to position the markings properly on the underlying shaft inalignment with anticipated boundaries of the working surface when theballoon is inflated, a tendency for mismatch remains due to severalpossible factors. One such factor may be the tolerance stack-ups arisingas a consequence of the affixation of the balloon to the distal end ofthe catheter shaft. The balloon also has a tendency to grow in thelongitudinal direction when inflated, especially with large andparticularly long balloons. Another factor is the tendency of theportion of the catheter shaft within the balloon to bend or flex duringinflation. This may lead to mis-alignment between markings M fixed tothe shaft S and the working surface W.

Whatever the cause, the resulting misalignment may prevent the clinicianfrom accurately identifying the location of the working surface of theballoon during an interventional procedure. This may lead to ageographic misplacement, or “miss,” of the intended contact between thetreatment area and the working surface of the balloon. It is especiallydesirable to avoid such an outcome when the balloon is designed todeliver a payload (such as a drug, stent, or both) or a working element(such as a cutter, focused force wire, or the like) to a specifiedlocation within the vasculature, since a miss may prolong the procedure(such as, for example, by requiring redeployment of the balloon or theuse of another balloon catheter in the case of a drug coated balloon).

In order to assess the length of a lesion from a location external tothe body, a clinician may also use an external ruler, which in one formis called a “LeMaitre” tape. While the use of such a ruler or tape mayallow for a more precise assessment of the lesion length and an areatreated by a pre-dilatation step, it is not without limitations. Forone, a displacement or difference in the apparent position of the lesionmargins results when viewed along two different lines of sight. This“parallax” can lead to an inaccurate measurement and, at a minimum,contribute to the geographic misalignment of the working surfacerelative to the lesion. The use of such an external ruler may also leadto inferior measurements when the vasculature at issue is particularlytortuous.

Accordingly, there is a need for a balloon for which the working surfacemay be identified during an interventional procedure with enhancedprecision. One solution would take into account the possible mismatchbetween fixed locations on the catheter shaft and the balloon to definethe working surface. Another would provide for a manner in which toposition a balloon catheter into the vasculature at a treatment areawith enhanced accuracy. Overall, procedural efficiency would be enhancedwithout remarkably increasing cost or complexity, and in a manner thatcan be applied to many existing catheter technologies without extensivemodification.

SUMMARY

An object of the disclosure is to provide a balloon for which theworking surface may be located during an interventional procedure withenhanced precision. A further object is to facilitate measuring alocation within the vasculature, such as for providing a treatmentduring a subsequent intervention.

In accordance with one aspect of the disclosure, a balloon catheter forinsertion in a vessel for treating a treatment area includes at leastthree radiopaque markings or markers spaced along a longitudinal axis ofthe catheter within the interior of the balloon. A first distanceseparating a first radiopaque marker or marking from a second adjacentradiopaque marking or marker is different from a second distanceseparating the second radiopaque marking or marker from a third adjacentradiopaque marking.

In one embodiment, a catheter shaft further includes an inner tubularmember forming a guidewire lumen, and which the tubular member includesthe at least three radiopaque markings or markers. The catheter shaftmay include an outer wall having at least one of the first or secondradiopaque markings or markers. The at least three markings or markersmay be spaced from a distal tip of the catheter.

The first distance may be smaller than the second distance. The firstradiopaque marking or marker may be distal to the second radiopaquemarking, which may be distal to the third radiopaque marking or markeralong the longitudinal axis. The radiopaque markings or markers may bearranged in a pattern comprising a plurality of adjacent pairs, withadjacent pairs being alternatingly separated by the first and seconddistances. A pattern of radiopaque markings or markers may compriseadjacent radiopaque markings or markers spaced at progressively largerdistances from one another from a distal point on the catheter to aproximal point on the catheter.

In these or other embodiments, the balloon includes an uninflatedmidpoint location and an inflated midpoint location. The catheter shaftincludes at least one first radiopaque marking or marker positioned atan offset location relative to the uninflated midpoint location. Oninflation of the balloon, the at least one radiopaque marking or markersubstantially aligns with the inflated midpoint location.

The balloon catheter may further include a second radiopaque marking ormarker corresponding to at least one end of the working surface of theballoon. The second radiopaque marking or marker may be provided on theballoon, or may be provided along an end section of the balloon adjacentto one end of the working surface. A third radiopaque marking or markermay also be provided at a location corresponding to another end of theworking surface.

The offset location may be spaced from the uninflated midpoint locationin a proximal or distal direction. As one example, the offset locationmay be spaced from the uninflated midpoint location a distanceapproximately 1-15% of a length between a distal end and a proximal endof the balloon in an inflated condition. However, the amount may varydepending on the circumstances.

The balloon catheter may further include at least one radiopaque markingor marker external to the interior of the balloon. The externalradiopaque marking or marker may be located on the shaft. An outer,tubular shaft may form an inflation lumen for supplying an inflationfluid to the balloon, and the external radiopaque marking or marker maybe located on the outer tubular shaft. A plurality of radiopaquemarkings or markers may be external to the interior of the balloon, andmay be regularly or irregularly spaced.

Another aspect of the disclosure relates to a balloon catheter forinsertion in a vessel for treating a treatment area, comprising acatheter shaft and an inflatable balloon attached to the catheter shaft.At least three radiopaque markings or markers extend along alongitudinal axis of the catheter. A first amount of non-radiopaquematerial separating a first radiopaque marking or marker from a secondradiopaque marking or marker is different from (e.g., having a lengthgreater than or less than) a second amount of non-radiopaque materialseparating the second radiopaque marking or marker from a thirdradiopaque marking.

In another aspect, the disclosure pertains to a balloon catheterincluding an elongated, tubular shaft. An inflatable balloon supportedby the shaft includes an uninflated midpoint location and an inflatedmidpoint location. The shaft further includes at least one firstradiopaque marking or marker positioned at an offset location relativeto the uninflated midpoint location. On inflation of the balloon, the atleast one radiopaque marking or marker substantially aligns with theinflated midpoint location.

In one embodiment, a second radiopaque marking or marker corresponds toat least one end of the working surface of the balloon. The secondradiopaque marking or marker may be provided on the balloon, such asalong a narrowed end section of the balloon adjacent one end of theworking surface. Alternatively, the second radiopaque marking or markermay be provided on the shaft at a location corresponding to a first endof the working surface. A third radiopaque marking or marker may beprovided on the shaft at a location corresponding to a second end of theworking surface.

A further aspect of the disclosure relates to a balloon catheter havingan elongated, tubular shaft and an inflatable balloon supported by theshaft. The balloon includes a working surface having a midpoint in aninflated condition. At least one first radiopaque marking or markercorresponds to the location of at least one end of the working surfacein the inflated condition. At least one second radiopaque marking ormarker corresponds to the location of the working surface midpoint.

The first radiopaque marking or marker may be located on the shaft.Further, a third radiopaque marking or marker corresponding to a secondend of the working surface may also be provided. The third radiopaquemarking or marker may be located on the shaft, and first radiopaquemarking or marker on the balloon.

Yet another aspect of the disclosure pertains to a balloon catheter,comprising an elongated, tubular shaft and an inflatable balloonsupported by the shaft. The balloon includes a working surface. Firstand second radiopaque markings or markers corresponding to the locationof the ends of the working surface, respectively, and a third radiopaquemarking or marker is positioned between the first and second radiopaquemarkings or markers.

The third radiopaque marking or marker may be closer to one of the firstor second markings or markers in the longitudinal direction. One or bothof the first and second radiopaque markings or markers may be providedon the shaft. The third radiopaque marking or marker may also beprovided on the shaft or on the balloon.

The first radiopaque marking or marker may be closer to a proximal endof the balloon, and the third radiopaque marking or marker may be closerto the first marking or marker than the second marking. The secondradiopaque marking or marker may be closer to a distal end of theballoon, and the third radiopaque marking or marker may be closer to thesecond marking or marker than the first marking.

In any of the disclosed embodiments, the balloon may be non-compliant,or may be compliant or semi-compliant. The balloon may further include atreatment, such as for example, a drug, stent, stent graft, orcombinations of the foregoing. The balloon catheters of any of theforegoing embodiments may further include a guidewire for guiding theballoon within the vasculature. The markings or markers in anyembodiment may comprise bands formed at least partially of a radiopaquematerial.

Any of the foregoing balloon catheters may be used in combination withanother balloon catheter including a working surface corresponding inlength to the spacing of at least two of the radiopaque markings ormarkers. The other balloon catheter may include a treatmentcorresponding in length to the spacing of at least two of the radiopaquemarkings or markers.

A further aspect of the disclosure relates to a balloon cathetercomprising an elongated, tubular shaft, and an inflatable balloonsupported by the shaft and having an interior. A plurality of firstradiopaque markings or markers are provided proximal of the balloon. Aplurality of second radiopaque markings or markers are provided withinthe interior of the balloon.

The tubular shaft may comprise an inner tubular shaft, and the firstradiopaque markings or markers are provided on an outer tubular shaftcoaxial with the inner tubular shaft. The first and second radiopaquemarkings or markers may be spaced equidistantly or non-equisitantly. Theplurality of second radiopaque markings or markers may comprise at leastthree markings or markers.

The disclosure may also be considered to relate to the use of theballoon catheter or catheters of any of the foregoing claims inperforming an angioplasty.

This disclosure also relates to methods of using a catheter to treat atreatment area. The catheter may include an inflatable balloon carriedby a shaft including at least one radiopaque marking or marker offsetfrom a midpoint location of the balloon in an uninflated condition. Themethod may comprise the step of aligning the offset radiopaque markingor marker (which may be on the shaft of the uninflated balloon) with acentral region of the treatment area. The method may further include thestep of inflating the balloon such that a working surface of the balloonwhen inflated corresponds to the treatment area.

A further aspect of the disclosure pertains to a method of measuring adistance within a vessel of a subject in combination with the use of aguidewire. The method comprises providing a catheter including a balloonand at least three radiopaque markings or markers within the balloon.The method further comprises determining a distance within the vesselusing the markings or markers. The determining step may comprisemeasuring a length of a lesion within the vessel, and may be completedprior to the step of introducing a catheter including a treatment intothe vessel.

This disclosure also describes a method of applying a therapeutic agentto a treatment area within a vessel of a subject. The method comprisesthe steps of: providing a measuring catheter including a plurality ofradiopaque markings or markers; measuring a length of the treatment areausing the measuring catheter; and providing a treatment balloon based onor corresponding to the measured length. The measuring catheter maycomprise a balloon, and the method may further comprise inflating theballoon at the treatment site. The measuring step may be conducted priorto inflation of the balloon on the measuring catheter. The measuringstep may be conducted subsequent to inflation of the balloon on themeasuring catheter. The method may further comprise the step ofpositioning the treatment balloon at the treatment site to deliver atherapeutic agent to the treatment area. The method may further includethe step of providing the treatment catheter with a balloon including aplurality of radiopaque markings or markers matching the markings ormarkers of the measuring catheter. The treatment catheter may include aballoon that is longer than the measuring balloon.

The present disclosure provides a balloon catheter comprising anelongated tubular shaft including a guidewire tubular member, aninflatable balloon supported by the shaft and having an interior, and aplurality of radiopaque markers along the guidewire tubular member bothwithin the balloon and along the catheter outside of the balloon.

The catheters of any of the foregoing embodiments may be in combinationwith a guidewire, including during use.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates schematically a balloon catheter in a vessel, andFIG. 2 illustrates the expanded balloon in the vessel.

FIGS. 3 and 4 illustrate schematically the use of fluorescence to detectthe balloon including a radiopaque contrast media.

FIGS. 5-9 illustrate various embodiments of balloon catheters.

FIG. 10 is a partially cutaway, schematic side view showing an offsetmarking or marker on a balloon catheter according to one embodiment ofthe disclosure.

FIG. 11 is a side view of the catheter of FIG. 10 with the marking ormarker in an aligned condition.

FIGS. 12 and 13 are partially cutaway, schematic side views illustratinguse of the balloon catheter of FIG. 10.

FIGS. 14 and 15 are additional views of another embodiment of a ballooncatheter according to the disclosure.

FIGS. 16 and 17 are additional views of yet another embodiment of aballoon catheter according to the disclosure.

FIGS. 18 and 19 are additional views of still another embodiment of aballoon catheter according to the disclosure.

FIG. 20 is a partially cutaway, schematic side view showing a marking ormarker pattern on a balloon catheter according to one embodiment of thedisclosure.

FIG. 21 is a partially cutaway, schematic side view showing anotherversion of a marking or marker pattern on a balloon catheter accordingto one embodiment of the disclosure

FIGS. 22 and 23 are partially cutaway, schematic side views showingvarious markings or markers on a balloon catheter according to oneembodiment of the disclosure.

FIGS. 24 and 25 are partially cutaway, schematic side views showingmarkings or markers on a balloon catheter according to one embodiment ofthe disclosure.

FIGS. 26, 27, and 28 illustrate an exemplary use of a balloon catheteraccording to the disclosure.

MODES FOR CARRYING OUT THE INVENTION

The description provided below and in regard to the figures applies toall embodiments unless noted otherwise, and features common to eachembodiment are similarly shown and numbered.

Provided is a catheter 10 having a distal portion 11 with a balloon 12mounted on a catheter tube 14. Referring to FIGS. 6, 7, and 8, theballoon 12 when inflated has an intermediate section 16, or “barrel,”and end sections 18, 20. In one embodiment, the end sections 18, 20reduce in diameter to join the intermediate section 16 to the cathetertube 14 (and thus sections 18, 20 are generally termed cones or conesections). The balloon 12 is sealed at balloon ends (proximal end 15 aand distal end 15 b) on the cone sections 18, 20 to allow the inflationof the balloon 12 via one or more inflation lumens 17 extending withincatheter tube 14 and communicating with the interior of the balloon 12.

As noted above and can be understood with reference to FIGS. 5 and 6,the catheter tube 14 also includes a shaft S for supporting the balloon12. The shaft S may be an elongated, tubular shaft 24 forming aguidewire lumen 23 that directs the guidewire 26 through the catheter10, and along the distal end of which the balloon 12 may be located. Thecone section 20 at the distal end 15 b of the balloon 12 may be fixed tothis shaft 24 adjacent the tip P. The balloon 12 at the opposite end isconnected to the tube 14, and is able to move relative to shaft 24 inorder to permit a degree of expansion in the longitudinal direction.

As illustrated in FIG. 8, this guidewire 26 may extend through theproximal end of the catheter 10 and a first port 25 of a connector 27into the lumen 23 to achieve an “over the wire” (OTW) arrangement, butcould also be provided in a “rapid exchange” (RX) configuration, inwhich the guidewire 26 exits a lateral opening 14a closer to the distalend (see FIG. 9) or else is fed through a passage associated with thetip P distally of the balloon 12 (“short” RX; not shown). A second port29 may also be associated with catheter 10, such as by way of connector27, for introducing a fluid (e.g., saline, a contrast agent, or both)into the interior compartment of the balloon 12 via the inflation lumen17.

Balloon 12 may include a single or multi-layered balloon wall 28 formingthe interior for receiving the inflation fluid. The balloon 12 may be anon-compliant balloon having a balloon wall 28 that maintains its sizeand shape in one or more directions when the balloon is inflated.Examples of non-compliant balloons may be found in U.S. Pat. No.6,746,425 and U.S. Patent Application Publication Nos. 2006/0085022,2006/0085023 and 2006/0085024, the disclosures of which are incorporatedby reference. The balloon 12 may comprise PET and/or fiberreinforcements. The balloon 12 in such case also has a pre-determinedsurface area that remains substantially constant during and afterinflation, also has a pre-determined length and pre-determined diameterthat each, or together, remain substantially constant during and afterinflation (subject to a relatively small amount of longitudinalexpansion (e.g., up to 5%) as the result of the material properties).However, the balloon 12 could be semi-compliant or compliant instead,depending on the particular use. Examples of materials for compliantballoons include latex and silicone, and for semi-compliant balloonsinclude polyamides (Nylon 11 or Nylon 12), polyimide block co-polymers(Pebax), polyurethanes (Pellethane), polycarbonate-based thermoplasticpolyurethanes (Carbothane).

In order to provide for enhanced locatability during an interventionalprocedure, and potentially without the use of contrast media, thecatheter 10 may have a radiopaque quality. In one embodiment, thisradiopaque quality is provided in a manner that allows for a clinicianto ensure the accurate positioning of the balloon 12 and, in particular,the working surface W created on inflation of the balloon, at aspecified treatment area T. This may be especially important in thedelivery of a particular treatment, such as a drug or stent, via theballoon working surface W, as outlined in more detail in the followingdescription.

In one embodiment, the radiopaque quality may be achieved by one or moreat least partially radiopaque markings or markers M associated with thecatheter 10. In a first embodiment, as shown in FIG. 10, the arrangementincludes at least one radiopaque marking or marker M. This marking ormarker M may take the form of a radiopaque material, such as a band 30.The band 30 may be associated with the shaft 24 passing through theinterior of the balloon 12 (which is schematically illustrated in FIG.10 in the uninflated, wrapped or folded condition to facilitate travelwithin the vasculature).

The marking, such as band 30, may be positioned at an initial locationO. This initial location O may be offset from the midpoint location A ofthe balloon 12 in the uninflated or wrapped condition. As illustrated,the midpoint location A is located between and spaced from the proximaland distal ends 15 a, 15 b of the balloon 12, along portion of theballoon wall 28 when folded that forms the barrel section 16 when theballoon 12 is inflated.

As indicated in FIG. 11, the offset location O of the marking or band 30corresponds to the midpoint location B of the working surface W wheninflated, such as may be the result of longitudinal expansion of theballoon 12 in the proximal direction C. Accordingly, the clinician mayposition the uninflated balloon 12 such that the marking or band 30 isat the desired midpoint or center region R of the treatment area T (suchas a lesion), yet offset from the midpoint location A of the wrappedballoon 12, as indicated in FIG. 12. Given that the offset location Otakes into account the amount of longitudinal expansion caused byinflation, the clinician is thus assured that the balloon 12, wheninflated and expanded, creates the desired profile such that the workingsurface W corresponds to the treatment area T.

As should be appreciated, the marking or band 30 remains at or adjacentthe center region R of the treatment area T, as originally placed in theuninflated condition, despite the expansion of the balloon 12 to formthe working surface W and provide the desired treatment. Consequently,the incidence of a possible geographic “miss” is reduced. This isprimarily because the balloon 12 expands in the longitudinal directionrelative to its pre-positioning at the center region R of the treatmentarea T as a result of the offset marking, instead of being positionedusing marker bands that do not necessarily correspond to the extent ofthe working surface W of the inflated balloon (see, e.g., FIG. 5).

The offset location O may be selected based on the predicted expansionof the balloon 12 in the longitudinal direction during inflation. Forinstance, the offset location O may be offset from the midpoint locationA approximately 1-15% of the full length of the expanded or inflatedballoon 12 (that is, the distance between the distal and proximal ends15 a, 15 b). This includes the amounts of less than to about 1%, about2%, about 3%, about 4%, about 5%, about 6%, about 7%, about 8%, about9%, about 10%, about 11%, about 12%, about 13%, about 14%, and about15%. The actual amount of offset used may be empirically determined orestimated, such as based on the properties of the materials used(including, for example, the type of material, shape, size, wallthickness, thermal expansion characteristics, and the like).

As indicated in FIG. 10, the offset location O may account for expansionin the proximal direction C upon inflation of the balloon 12. However,it is also possible to account for expansion in the distal direction Dby positioning the marking, such as band 30, at a location distally fromthe midpoint location A, as shown in FIG. 14. Thus, as indicated in FIG.15, the longitudinal expansion of the balloon 12 causes the marking orband 30 to align substantially with the midpoint location 13 of theworking surface W in the desired manner. The positioning of the markerat the offset location O may also be such that it takes into accountexpansion in both the proximal and distal directions, C, D.

Turning to FIGS. 16 and 17, it can be understood that further markingsor markers may be provided on the catheter 10, such as within theballoon 12. For example, markings or markers may be associated with theshaft 24 in the form of bands 32, 34. These bands 32 may be formed atleast partially of a radiopaque material. The bands 30, 32 initiallyindicate locations E, F adjacent the proximal and distal ends 15 a, 15 bof the balloon 12 in the uninflated condition, and thus aid theclinician in understanding the relative location of the distal andproximal ends 15 a, 15 b of the balloon 12. The marking, such as band30, at the offset location O is thus used to position the balloon 12 inconnection with the other markings or markers (e.g., bands 32, 34) priorto inflation, but the expansion is such that the midpoint location B ofthe working surface W corresponds to the location of the band 30 oninflation.

Thus, as can be appreciated, at least three markings or markers arepresent in this embodiment, such as bands 30, 32, 34, and which markingsor markers are not spaced equidistantly in the longitudinal direction.For example, in the illustrated embodiment, band 30 is closer toproximal band 32 than distal band 34. In other words, the non-radiopaqueportion separating one pair of markings or markers is larger or smallerthan the non-radiopaque material separating the other pair of markingsor markers. Despite this irregular spacing, all three markings ormarkers in the illustrated embodiment remain within the interiorcompartment of the balloon 12 and, in particular, the portioncorresponding to the working surface W.

Markings or markers may also be provided on the balloon 12 in order tohelp determine relative locations during the procedure. For example, asshown in FIGS. 18 and 19, the marking offset from the midpoint locationA may be provided in the form of a band 30 along the shaft 24, and amarking 36 may be associated with the balloon 12, such as along theconical portion or section 20 adjacent the tip P at the distal end ofthe catheter 10 (but possibly at the proximal end instead, or at bothlocations). Thus, as a result of the longitudinal expansion of theballoon 12 on inflation, the marking or band 30 on the shaft 24 alignswith the midpoint location B of the working surface W. The marking onthe balloon 12 may comprise a foil, film, adhesive, coating, or the likeapplied on the surface or within one or more interior layers forming theballoon wall 28. Also, such a marking may also be provided on conicalportion 18 of balloon 12 for indicating the proximal end of the workingsurface W.

With reference to FIG. 20, the catheter 10 may be provided with one ormore markings or markers M for use in measuring a dimension within avessel. The markings or markers M may be radiopaque in nature, and maybe applied to a tubular member within the catheter 10, such as theguidewire tubular member 24. The markings or markers M may by appliedwithin the balloon 12 so as to measure a dimension of a structure, suchas a lesion to be dilated, within a vessel, as may be seen, for example,in FIGS. 27 and 28. In one aspect, the markings or markers M may act asa ruler to measure a linear distance when positioned within the vessel.

FIGS. 21-25 illustrate certain embodiments of the catheter 10 withmarkings or markers M placed at various distances from one another andupon various elements of the catheter 10. As shown in FIG. 21, themarkings or markers M may be equidistant from one another. Thesemarkings or markers M may be placed along the guidewire tubular member24 within the balloon 12 alone as shown in FIG. 20, or along theguidewire tubular member 24 both within the balloon 12 and along thecatheter 10 outside of the balloon 12, as shown in FIG. 21. As should beappreciated, at least three markings or markers M appear in the interiorof balloon 12 in the illustrated embodiment and, in particular, withinthe boundary of the location providing the balloon working surface W(that is, one marking or marker is provided adjacent to a first edge ofthe working surface W, a second marker or marking is provided adjacentto a second edge of the working surface W, and a third marking or markeris between the two edge markings or markers).

In certain embodiments, as shown in FIGS. 20 and 21, the markings ormarkers M may be placed equidistant from one another along the entirelength of the catheter 10, including the portion including the balloon12. The distance between the markings or markers M may range from smalldistances for measuring fine measurements (e.g., less than about 1millimeter between markings or markers M and up to about 10millimeters), average or medium measurements (e.g., about 10 millimetersbetween markings or markers M), or large measurements (e.g., greaterthan 10 millimeters between markings or markers M).

FIG. 22 illustrates a further embodiment of the catheter 10 includingmarkings or markers M. In this embodiment, the markings or markers M maybe positioned on the catheter tube 14. In one aspect, the markings ormarkers M may be placed on the catheter tube 14, such as along the outersurface. The markings or markers M may be on the catheter tube 14 alone,or as illustrated, the markings or markers may be on both the cathetertube 14 and the guidewire tubular member 24. The markings or markers Mmay be equidistant from each other, or may be non-equidistant.

With reference to FIG. 23, the markings or markers M may be positionedwith a first distance D₁ between markings or markers M at a firstlocation on the catheter, and with a second distance D₂ between markingsor markers M at a second location on the catheter. In one example, themarkings or markers M within the balloon 12 may be positioned with afirst distance D₁ between the markings or markers, while the markings ormarkers M at a position outside the balloon along the catheter tube 14may be positioned with a second distance D₂ between markings or markers.In the illustrated embodiment, the first distance D₁ may be less thanthe second distance D₂. This may allow for gross measurements ofdistance on a proximal portion of the catheter 10, while allowing formore fine measurements of a distance on a distal portion of the catheter10.

FIG. 24 illustrates a further embodiment in which markings or markers Mmay be positioned with varying distances therebetween, such that themarkings or markers M are not equidistant from one another. As shown, athird distance D₃ may exist between first and second adjacent markingsor markers M₁, M₂. Additionally, second and third adjacent markings ormarkers M₂, M₃ may be positioned such that a fourth distance D₄separates these markings or markers M₂, M₃. The third distance D₃ may beless than the fourth distance D₄. In one embodiment, the third distanceD₃ may be, for example, about 5 millimeters, and the fourth distance D₄may be, for example, about 10 millimeters. The distance between markingsor markers M may alternate between the third distance D₃ and the fourthdistance D₄ along the length of the catheter 10. This alternatingdistance between markings or markers M may allow for fine or grossmeasurements at various points along the length of the catheter 10.

With reference to FIG. 25, another embodiment is disclosed wherein themarkings or markers M₄, M₅, M₆ . . . M_(n) may be placed along thecatheter 10 in a non-equidistant manner. As shown, the distance betweenmarkings or markers M may increase from a distal end of the catheter 10to a proximal end of the catheter 10. For example, a fifth distance D₅may exist between fourth and fifth markings or markers M₄, M₅ on adistal end of the catheter 10. Similarly, a sixth distance D₆, proximalto the fifth distance D₅, may exist between the fifth and sixth markingsor markers M₅, M₆, and a seventh distance D₇ may exist between the sixthand seventh markings or markers M₆, M₇. The distance between eachsuccessive pair of adjacent markings or markers M from a distal end ofthe catheter 10 to a proximal end of the catheter 10 may incrementallyincrease with respect to the previous pair of markings or markers Mthrough a final distance D_(n). In the FIG. 25 example, D₅<D₆<D₇< . . .D_(n). Stated another way, the distance between markings or markers Mmay incrementally and continually decrease from a proximal end of thecatheter 10 to a distal end. This decrease in distance between adjacentmarkings or markers M may allow for progressively finer measurements tobe taken toward the distal end of the catheter 10.

FIGS. 26-28 illustrate uses of a catheter 10 with radiopaque markings ormarkers M for measuring a treatment area T and delivery of a treatmentballoon 112 to the treatment area T. FIG. 26 shows a balloon 12 of thecatheter 10 including a plurality of markings or markers M beinginserted along a guidewire 26 into a vessel V to a treatment area T,such as a lesion L, using a device called an introducer I. The balloon12 may be inflated at the treatment area T so as to dilate the vessel Vand compress the lesion L, as shown in FIG. 27. The balloon 12 may bedeflated and removed after use.

The plurality of markings or markers M along the catheter 10 may bespaced at pre-determined intervals from one another so as to demarcateknown distances therebetween. These markings or markers M may be used tomeasure a length of the treatment area T, which in the illustratedembodiment constitutes the distance spanning the length of lesion L.Markings or markers M may be used to measure the length of the treatmentarea T before and/or after dilation of the balloon 12. With precisemeasurement of the desired or necessary treatment area T, the user mayselect an appropriate treatment balloon 112 for the task (which may alsobe provided as part of a combination with a measuring balloon). Forexample, the user may select a treatment balloon 112 with a workingsurface corresponding in length to the measurement obtained, or anassociated treatment catheter 110 (FIG. 28) for treatment with markersor markings corresponding to the markers or markings of the catheter 10

As shown in FIG. 28, the selected treatment catheter 110 (which againmay be substantially identical in construction to catheter 10, and maythus include matching radiopaque markings or markers, including forexample an offset marking for aligning with the center region) may thenbe inserted to position the treatment balloon 112 at the treatment areaT. The treatment balloon 112 may include a working surface W₂ includinga treatment, such as for example a therapeutic agent (e.g., a drug, suchas paclitaxel, rapamycin, heparin and the like), a stent, a stent graft,or a combination). In some cases, the treatment balloon 112 may belonger than the balloon of the measuring catheter (so as to ensure fullcoverage of the lesion L during the subsequent intervention; e.g., thefirst balloon may be 20 millimeters, and the second balloon may be 40millimeters). Common positioning of the catheters 10, 110 may be done inrelation to a common location within the body visible under fluoroscopy,such as a bony landmark (e.g., a particular vertebrae).

In the case of delivering a treatment, selection of a length of workingsurface W₂ may be important so as to treat the entire treatment area T,but to treat no more than treatment area T. A treatment balloon 112 witha length of a working surface W₂ corresponding to the measured distanceof the treatment area T may be selected based on the measured length oftreatment area T with the measuring catheter 10. In this manner, aclinician may be assured that the delivery of the treatment is achievedin the intended manner to the entire treatment area T, but notelsewhere, which may aid in avoiding geographic misalignment, failure totreat an entire treatment area T, or overdose of the therapeutic agentoutside the treatment area T. Consequently, the procedure is potentiallyshortened, and a further intervention may be avoided. The measurementtechnique may also be used post-dilatation, if desired.

As suggested by the foregoing, any of the disclosed balloons 12 maycarry treatment in the form of one or more treatment agents, such as apayload (drug, stent, or both) or a working implement (cutter, focusedforce wire, or the like). For example, as shown in FIG. 17, a balloon 12with a defined working surface W (such as by providing markings ormarkers M in the form of radiopaque bands 32, 34 at the transitionsbetween the barrel section 16 and end sections 18, 20), may include atleast a portion coated with such a drug G, such as one designed forachieving a desired therapeutic effect when applied to the interior ofthe vessel. The drug G forming this treatment may be applied to theballoon 12 as part of the manufacturing process, including possiblyprior to folding for insertion in the vasculature or after folding iscompleted. The clinician may thus with the benefit of a fluoroscopedetermine the precise positioning of the working surface W prior toinflating the balloon 12 in the vasculature to deliver the drug G to thedesired location and provide the desired treatment, which may form partof a treatment regimen.

Examples of radiopaque materials that may be used herein for themarkings or markers on the catheter 10 (balloon 10 or shaft 24) include,but are not limited to, finely divided tungsten, tantalum, bismuth,bismuth trioxide, bismuth oxychloride, bismuth subcarbonate, otherbismuth compounds, barium sulfate, tin, silver, silver compounds, rareearth oxides, and many other substances commonly used for X-rayabsorption. The amount used may vary depending on the desired degree ofradiopacity, and in any form (e.g., bands, foil, films (including withembedded radiopaque powders), decals, paints, coatings, etc.). In oneembodiment, the markings or markers M may comprise a polymer loaded witha radiopaque element such as iodine, iopromide, metallic ions, gold,barium sulfate, tungsten, bismuth trioxide, or other similarlyfunctional materials. The radiopaque materials may be used in the formof gels, powders, dust, particles, nano-particles, liquids, stains,adhesives and the like. The radiopaque material forming the marking ormarker could be anywhere from about 5-95% radiopaque or, morespecifically, in the range of about 70-90% radiopacity.

The markings or markers M may take the form of metal marker bands, suchas platinum, iridium and/or gold markings or markers, which may beswaged, glued, or otherwise affixed to the catheter 10. In oneembodiment, the catheter may include heat-bonded radiopaque segmentsinterspersed between non-radiopaque segments. In a further embodiment,the markings or markers M may comprise a radiopaque tape or film appliedto the catheter 10. A radiopaque ink may also be used to form themarkings or markers M. While bands are mentioned above and illustratedin the figures, the markings or markers M may take the form of symbols(numbers, letters), geometric shapes (gradation lines, hash marks, dots,etc.), or combinations of one or more of the foregoing. Theaforementioned marking or marker compounds are exemplary of variousradiopaque markings or markers currently used in medicine, but themarking or marker may include any technique that allows forvisualization of a particular location during use in the vasculature.

While the disclosure presents certain embodiments to illustrate theinventive concepts, numerous modifications, alterations, and changes tothe described embodiments are possible without departing from the sphereand scope of the present invention, as defined in the appended claims.For example, any ranges and numerical values provided in the variousembodiments are subject to variation due to tolerances, due tovariations in environmental factors and material quality, and due tomodifications of the structure and shape of the balloon, and thus can beconsidered to be approximate and the term “approximately” means that therelevant value can, at minimum, vary because of such factors. Also, thedrawings, while illustrating the inventive concepts, are not to scale,and should not be limited to any particular sizes or dimensions.Accordingly, it is intended that the present disclose not be limited tothe described embodiments, but that it has the full scope defined by thelanguage of the following claims, and equivalents thereof.

1. A balloon catheter comprising: an elongated, tubular shaft; aninflatable balloon supported by the shaft and having an interior; aplurality of first radiopaque markings proximal of the balloon; and aplurality of second radiopaque markings within the interior of theballoon.
 2. The balloon catheter of claim 1, wherein the elongatedtubular shaft comprises an inner tubular shaft, and the first radiopaquemarkings are provided on an outer tubular shaft coaxial with the innertubular shaft.
 3. The balloon catheter of claim 1, wherein the firstradiopaque markings are spaced equidistantly.
 4. The balloon catheter ofclaim 1, wherein the second radiopaque markings are spacedequidistantly.
 5. The balloon catheter of claim 1, wherein the firstradiopaque markings are not spaced equidistantly.
 6. The ballooncatheter of claim 1, wherein the second radiopaque markings are spacedequidistantly.
 7. The balloon catheter of claim 1, wherein the pluralityof second radiopaque markings comprise at least three markings.
 8. Theballoon catheter of claim 1, wherein the plurality of second radiopaquemarkings have a first distance between each of the second radiopaquemarkings and the first radiopaque markings have a second distancebetween each of the first radiopaque markings, wherein the firstdistance is less than the second distance.
 9. The balloon catheter ofclaim 1, wherein the plurality of first radiopaque markings havedifferent spacings between adjacent pairs of markings.
 10. The ballooncatheter of claim 1, wherein the plurality of second radiopaque markingshave different spacings between adjacent pairs of markings.
 11. Aballoon catheter, comprising: an elongated, tubular shaft; an inflatableballoon supported by the shaft, the balloon including a working surfacehaving a midpoint in an inflated condition; at least one firstradiopaque marking located on the balloon and corresponding to thelocation of one end of the working surface in the inflated condition;and at least one second radiopaque marking located on the shaft andcorresponding to the location of the midpoint of the working surface inthe inflated condition, further including a third radiopaque markingcorresponding to the other end of the working surface and located on theshaft.